Phase III trial of ADS 5102 (amantadine HCl) shows improvements in levodopa-induced dyskinesia in Parkinsons disease- Adamas Pharmaceuticals

Adamas Pharmaceuticals has announced positive findings from its lead Phase III study (EASE LID) evaluating ADS 5102 (amantadine HCl) extended-release capsules for the treatment of levodopa-induced dyskinesia (LID) associated with Parkinson’s disease (PD). Results from this randomized, double-blind, placebo-controlled study showed a statistically significant improvement in LID at 12 weeks for patients who received ADS 5102 versus placebo as assessed by the Unified Dyskinesia Rating Scale (UDysRS). The improvement in LID was maintained at 24 weeks, a key secondary analysis. The percent reduction from the observed mean UDysRS total score at baseline compared to that at week 12 was 42 percent in the ADS 5102 group and 19 percent in the placebo group. The least square (LS) mean treatment difference at week 12 was statistically significant.

Similarly, the percent reduction in observed mean UDysRS total score from baseline to week 24 was 40 percent in the ADS 5102 group and 16 percent in the placebo group. The LS mean treatment difference at week 24 was statistically significant. An anti-dyskinetic effect achieved by ADS 5102 was also demonstrated across multiple outcome measures, providing further data suggestive of a clinically meaningful benefit. The reported adverse events (AEs) associated with ADS 5102 were consistent with the known safety profile of amantadine as well as safety results from the Phase 2/3 placebo-controlled study (EASED). These results were presented at the 68th American Academy of Neurology Annual Meeting.